MoonLake Immunotherapeutics Inc. (MLTX), a clinical-stage biopharmaceutical company, on Sunday, announced that its pre-BLA meeting with the FDA regarding its Hidradenitis suppurativa drug candidate sonelokimab yielded positive feedback, and it also reported financial results for the first quarter of 2026.
Sonelokimab (SLK) is an investigational nanobody being developed to treat dermatological indications like hidradenitis suppurativa (HA), psoriatic arthritis (PsA), plaque psoriasis, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
Data from the Phase 3 VELA-1 and VELA-2 trials of Sonelokimab in hidradenitis suppurativa indicate a statistically significant improvement in the primary endpoint of higher clinical response level of HS Clinical Response (HiSCR) 75. Previously, a 43% response rate for HiSCR was reported from the Phase 2 MIRA trial.
In the pre-BLA meeting on April 1, 2026, MoonLake used safety data from the VELA-2, MIRA, and the VELA-TEEN trials to validate the submission for SLK in treating patients with Hidradenitis suppurativa.
The company achieved alignment with the FDA on the submission plan, label strategy, the approach to include adolescent HS data in the BLA, and safety data strategy.
Upcoming Milestones:
52-week data from the VELA-1 and VELA-2 trials are expected in the second quarter, while primary endpoint readouts from the Phase 3 VELA-TEEN trial of SLK in adolescent HS patients are expected in mid-2026.
The company also plans to apply for a priority review associated with the VELA-TEEN data and will submit a complete BLA application to the FDA in September of this year. The FDA may accordingly grant acceptance within 60 days and verify the priority review status.
The launch of sonelokimab is planned for the second half of 2027.
SLK is additionally being evaluated for the treatment of PsA in the Phase 3 IZAR-1 and IZAR-2 trials, and primary endpoint data is anticipated for mid-2026 and Q4 2026, respectively.
Q1 2026:
The company recorded net other income of $3.21 million in Q1 2026, compared to the $4.44 million reported a year ago. A net loss of $69.71 million, or $0.98 per share, was recorded in Q1 2026, while Q1 2025 showed a loss of $63.02 million, or $0.91 per share.
Research and development expenses (R&D) for the first quarter were $54.50 million, while in the same period of the previous year, R&D expenses were $56 million.
Cash, cash equivalents, and short-term marketable debt securities amounted to $357.90 million as of March 31, 2026.
MLTX closed Friday at $17.06, down 0.81%. In the pre-market, shares are trading at $17.50, up 2.58%
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